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Quality Assurance Monitor

Description:

Primary Function:

The monitor reviews all clinical trials conducted by the institution. Extra emphasis is placed on the therapeutic investigator initiated studies being conducted within hospital initiated multisite trials. The monitor ensures protocol compliance and data quality internally and at the clinical research sites via remote and on-site monitoring.

Essential Functions:

• The monitor is responsible for proactive noncompliance issue identification, escalation, and creation of Corrective and Preventative Actions.

• Participate in audit preparation, hosting, and post-audit activities to promote the successful outcome of the audit.

• Provide interpretation and guidance for internal and external customers on clinical quality related regulations / guidelines (FDA, ICH GCP, etc.) and TJU/SKCC policies.

• Maintain knowledge of current GCP standards and FDA regulations.

• Participate in the development or revision of SOPs to support compliance.

• Conduct clinical research training for new hires, existing staff, clinical investigators, and other Jefferson enterprise staff as needed

Other Core Functions and Competencies:

• Assists the Quality Assurance and Process Improvement Unit with administrative responsibilities.

• Interacts with co-workers and other staff consistent with the core values of the University.

Performs other duties as assigned.

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Company
ACtalent
Posted
07/15/2021
Type
Contractor
Location
Philadelphia, PA, US